You are here

Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

Last updated on November 13, 2019

FOR MORE INFORMATION
Study Location
Seoul National University Hospital
Seoul, , 03080 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid
tumors that are not amenable for treatment with curative intent in adult patients
with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC,
CRPC, and other advanced solid tumors with a BRCA or ATM gene defect

- Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available
from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor
biopsy during the screening period.

- Minimum age in Japan is 20 years.

- ECOG performance status 0 or 1.

- Resolved acute effects of prior therapy

- Adequate bone marrow, renal, and liver function.

- Negative serum pregnancy test at screening.

- Pregnant, breastfeeding females or female patients able to have children must agree to
use highly effective method of contraception throughout the study and for at least 30
days after the last dose of avelumab and for at least 7 months after the last dose of
talazoparib; fertile male patients must use a condom during treatment and for at least
4 months after the last dose of talazoparib.

- Signed and dated informed consent.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with a PARP inhibitor.

- Prior immunotherapy with IL-2, IFN-?, or an anti-PD-1, anti-PD-L1, anti-PD-L2,
anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody
or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2
NSCLC patients prior treatment with anti-PD-1/L1 is allowed

- Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation
therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to
metastatic lesion(s) is permitted, provided it has been completed 2 days prior to
study enrollment and no clinically significant toxicities are expected (eg, mucositis,
esophagitis).

- Major surgery within 4 weeks prior to study enrollment.

- Current use of immunosuppressive medication at the time of study enrollment.

- Known prior or suspected hypersensitivity to investigational products.

- Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis,
pulmonary fibrosis.

- Active or prior autoimmune disease that might deteriorate when receiving an
immunostimulatory agent.

- Prior organ transplantation including allogenic stem-cell transplantation.

- Vaccination within 4 weeks of study enrollment and while on trial is prohibited except
for administration of inactivated vaccines.

- Diagnosis of Myelodysplastic Syndrome.

- Patients with known brain metastases requiring steroids.

- Participation in other studies involving investigational drug(s) within 4 weeks prior
to study participation and/or during study participation.

- Persisting toxicity related to prior therapy >Grade 1

- Known HIV or AIDs-related illness.

- Positive HBV or HCV test indicating acute or chronic infection.

- Active infection requiring systemic therapy.

- Clinically significant cardiovascular disease: cerebral vascular accident/stroke or
myocardial infarction within 6 months prior to study entry; unstable angina,
congestive heart failure or a serious cardiac arrhythmia requiring medication.

- Current or anticipated use within 7 days prior to first dose of study drug, or
anticipated use during the study of a strong P-gp inhibitor.

- Other acute or chronic medical or psychiatric conditions.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Capsules
Intravenous injections
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
A placebo is not used in this trial
Duration
The time commitment for participation in the study.
Follow up: Estimated 12 weeks
Screening: Estimated 4 weeks
Treatment: Estimated 36 weeks
Site Visits
Follow up: Range 0 visits
Screening: Range 1 visits
Treatment: Range 1 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Keeping a diary
Mri
Cat scan
Physical examination
Electrocardiogram (ECG)
Biopsy
Urine test
Other
Blood test
Vital signs and measurements
NCT03330405
Pfizer
Recruiting
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
Official Title  ICMJE A PHASE 1B/2 STUDY TO EVALUATE SAFETY AND ANTI TUMOR ACTIVITY OF AVELUMAB IN COMBINATION WITH THE POLY(ADENOSINE DIPHOSPHATE [ADP]-RIBOSE) POLYMERASE (PARP) INHIBITOR TALAZOPARIB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Brief SummaryAvelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).
Detailed Description

Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD L1). Avelumab selectively binds to PD L1 and competitively blocks its interaction with programmed death receptor 1 (PD 1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies.

Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription.

Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors, including non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), hormone receptor positive (HR+) breast cancer, recurrent platinum sensitive ovarian cancer, urothelial cancer (UC), and castration resistant prostate cancer (CRPC).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
Intervention  ICMJE
  • Drug: Avelumab Phase 1b
    Avelumab
    Other Name: MSB0010718C
  • Drug: Talazoparib Phase 1b
    Talazoparib
    Other Name: MDV3800, BMN 673
  • Drug: Avelumab Phase 2
    The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
    Other Name: MSB0010718C
  • Drug: Talazoparib Phase 2
    The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
    Other Name: MDV3800, BMN 673
Study Arms  ICMJE
  • Experimental: Dose Level 0 Phase 1b

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 1b
    • Drug: Talazoparib Phase 1b
  • Experimental: Dose Level -1 Phase 1b

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 1b
    • Drug: Talazoparib Phase 1b
  • Experimental: Dose Level -2 Phase 1b

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 1b
    • Drug: Talazoparib Phase 1b
  • Experimental: A1. NSCLC Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: A2. NSCLC PD-L1 Resistant DDR+ Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: B1. TNBC Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: B2. HR+BC DDR Defect +Assay Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: C1. Ovarian CA Recurrent Plat-Sensitive Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: C2.Ovarian CA Recurrent Plat-Sensitive BRCA defect Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: D.Urothelial CA Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: E1. CRPC Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: E2. CRPC DDR Defect +Assay Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
  • Experimental: F: Advanced Solid Tumors with BRCA or ATM defect Phase 2

    Drug: Avelumab

    Drug: Talazoparib

    Interventions:
    • Drug: Avelumab Phase 2
    • Drug: Talazoparib Phase 2
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
242
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
296
Estimated Study Completion Date  ICMJE August 4, 2020
Estimated Primary Completion DateAugust 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histological diagnosis of locally advanced (primary or recurrent) or metastatic solid tumors that are not amenable for treatment with curative intent in adult patients with: NSCLC, TNBC, HR+ breast cancer, recurrent platinum sensitive ovarian cancer, UC, CRPC, and other advanced solid tumors with a BRCA or ATM gene defect
  • Mandatory primary or metastatic tumor biopsy. If archival tumor tissue is available from a biopsy/surgery the tumor tissue may be submitted without repeating a tumor biopsy during the screening period.
  • Minimum age in Japan is 20 years.
  • ECOG performance status 0 or 1.
  • Resolved acute effects of prior therapy
  • Adequate bone marrow, renal, and liver function.
  • Negative serum pregnancy test at screening.
  • Pregnant, breastfeeding females or female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 30 days after the last dose of avelumab and for at least 7 months after the last dose of talazoparib; fertile male patients must use a condom during treatment and for at least 4 months after the last dose of talazoparib.
  • Signed and dated informed consent.

Exclusion Criteria:

  • Prior treatment with a PARP inhibitor.
  • Prior immunotherapy with IL-2, IFN-?, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, OX 40, GITR, LAG 3, IDO, TDO,TIM 3, CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways. Prior treatment with Sipuleucel-T for patients with mCRPC is allowed. For cohort A2 NSCLC patients prior treatment with anti-PD-1/L1 is allowed
  • Prior anti-cancer therapy within 2 weeks prior to study enrollment. Prior radiation therapy within 2 weeks prior to enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed 2 days prior to study enrollment and no clinically significant toxicities are expected (eg, mucositis, esophagitis).
  • Major surgery within 4 weeks prior to study enrollment.
  • Current use of immunosuppressive medication at the time of study enrollment.
  • Known prior or suspected hypersensitivity to investigational products.
  • Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
  • Active or prior autoimmune disease that might deteriorate when receiving an immunostimulatory agent.
  • Prior organ transplantation including allogenic stem-cell transplantation.
  • Vaccination within 4 weeks of study enrollment and while on trial is prohibited except for administration of inactivated vaccines.
  • Diagnosis of Myelodysplastic Syndrome.
  • Patients with known brain metastases requiring steroids.
  • Participation in other studies involving investigational drug(s) within 4 weeks prior to study participation and/or during study participation.
  • Persisting toxicity related to prior therapy >Grade 1
  • Known HIV or AIDs-related illness.
  • Positive HBV or HCV test indicating acute or chronic infection.
  • Active infection requiring systemic therapy.
  • Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months prior to study entry; unstable angina, congestive heart failure or a serious cardiac arrhythmia requiring medication.
  • Current or anticipated use within 7 days prior to first dose of study drug, or anticipated use during the study of a strong P-gp inhibitor.
  • Other acute or chronic medical or psychiatric conditions.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Denmark,   Hungary,   Korea, Republic of,   Russian Federation,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330405
Other Study ID Numbers  ICMJE B9991025
2017-001509-33 ( EudraCT Number )
JAVELIN PARP MEDLEY ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now